Consent form toxin

L3 Aesthetics consent form for

BOTOX / XEOMIN / JEUVEAU / DYSPORT / DAXXIFY

GENERAL INFORMATION

Clostridia botulina bacteria produce a class of chemical compounds known as “toxins.” The Botulina Type A Toxin (neuromodulators) is processed and purified to produce a sterile product suitable for specific therapeutic uses. Once the diluted toxin is injected, it produces a temporary paralysis (chemodenervation) of muscle by preventing transmission of nerve impulses to muscle. The duration of muscle paralysis generally lasts for approximately three to four months. Neuromodulators have been approved to treat certain conditions involving crossed eyes (strabismus), eyelid spasm (blepharospasm), cervical dystonia (spastic muscle disorder with the neck) and motor disorders of the facial nerve (VII cranial nerve). It has been FDA-approved for the cosmetic treatment of forehead wrinkles and “crow’s feet” area caused by specific muscle groups. Neuromodulators have also been used to treat migraine headaches, colorectal disorders, excessive perspiration disorders of the armpit and hands, and musculoskeletal pain disorders. Neuromodulator injections are customized for every patient, depending on his or her particular needs. These can be performed in areas involving eyelid region, forehead and neck. Neuromodulators cannot stop the process of aging. It can however, temporarily diminish the look for wrinkles caused by muscle groups. Neuromodulator injections may be performed as a singular procedure or as an adjunct to a surgical procedure.

ALTERNATIVE TREATMENTS

Alternative forms of management include not treating the skin wrinkles by any means. Improvement of skin wrinkles may be accomplished by other treatments or alternative types of surgery such as blepharoplasty, face or brow lift when indicated. Other forms of eyelid surgery may be needed should you have intrinsic disorders affecting the function of the eyelid such as drooping eyelids from muscle problems (eyelid ptosis) or looseness between the eyelid and eyeball (ectropin). Minor skin wrinkling may be improved through chemical skin peels, micro-needling, lasers, injection of filling material, or other skin treatments. Risks and potential complications are associated with alternative forms of medical or surgical treatment.

RISKS of BOTOX/Xeomin/Jeuveau/Dysport/Daxxify Injections

Every procedure involves a certain amount of risk and it is important that you understand these risks and the possible complications associated with them. In addition, every procedure has limitations. An individual’s choice to undergo a surgical procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience these complications, you should discuss each of them with your plastic surgeon to make sure you understand risks, potential complications, limitations, and consequences of neuromodulator injections. Additional information concerning neuromodulators may be obtained from the package-insert sheets supplied by the company. Incomplete Block: It is possible to not experience a complete block of desired muscles. Additional injections to reach the desired level of block can be performed until the goal is achieved. Asymmetry: The human face and eyelid region is normally asymmetrical with respect to structural anatomy and function. There can be a variation from one side to the other in terms of the response to neuromodulator injections. Drooping Eyelid (Ptosis): Muscles that raise the eyelid may be affected by neuromodulators, should this material migrate downward from other injection areas. Pain: Discomfort associated with neuromodulator injections is usually of short duration. Migration of neuromodulators: Neuromodulators may migrate from its original injection site to other areas and produce temporary paralysis of other muscle groups or other unintended effects. Neuromodulators have been reported to cause swallowing problems in patients treated for spastic muscle disorders of the cervical region (cervical dystonia). Bleeding and Bruising: It is possible, though unusual, to have a bleeding episode from a neuromodulator injection. Bruising in soft tissues may occur. Serious bleeding around the eyeball during deeper neuromodulator injections for crossed eyes (strabismus) has occurred. Should you develop post-injection bleeding, it may require emergency treatment or surgery. Aspirin, anti-inflammatory medications, platelet inhibitors, anticoagulants, Vitmain E, ginkgo biloba, and other “herbs / homeopathic remedies” may contribute to a greater risk of a bleeding problem. Do not take these for ten days before neuromodulator injections. Damage to Deeper Structures: Deeper structures such as nerves, blood vessels, and the eyeball may be damaged during the course of injections. Injury to deeper structures may be temporary or permanent. Corneal Exposure Problems: Some patients experience difficulties closing their eyelids after neuromodulator injections and problems may occur in the cornea due to dryness. Should this rare complication occur, additional treatments, protective eye drops, contact lenses or surgery may be necessary. Unknown Risks: The long-term effect of neuromodulators on tissue is unknown. The risk and consequences of accidental intravascular injection of neuromodulators is unknown and not predictable. There is the possibility that additional risk factors may be discovered. Dry Eye Problems: Individuals who normally have dry eyes may be advised to use special caution in considering neuromodulator injections around the eyelid region. Double-Vision: Double-vision may be produced if the neuromodulator material migrates into the region of muscles that control movements of the eyeball. Eyelid Ectropion: Abnormal looseness of the lower eyelid can occur following neuromodulator injections. Other Eye Disorders: Functional and irritative disorders of eye structures may rarely occur following neuromodulator injections. Blindness: Blindness is extremely rare after neuromodulator injections. However, it can be caused by internal bleeding around the eyeball or needle stick injury. In a period of 10 years of neuromodulator administration, complications of blurred vision, retinal vein occlusion and glaucoma have been reported in three patients. The occurrence of eye problems appears to be very rare. Allergic Reactions: As with all biologic products, allergic and systemic anaphylactic reactions may occur. Allergic reactions may require additional treatment. Antibodies to neuromodulators: Presence of antibodies to neuromodulators may reduce the effectiveness of this material in subsequent injections. The health significance of antibodies to neuromodulators is unknown. Infection: Infection is extremely rare after neuromodulator injections. Should an infection occur, additional treatment including antibiotics may be necessary. Skin Disorders: Skin rash, itching, and swelling may rarely occur following neuromodulator injection. Neuromuscular Disorders: Patients with peripheral motor neuropathic disorders (amyotrophic lateral sclerosis, myasthenia gravis, motor neuropathies) may be at greater risk of clinically significant side effects from neuromodulators. Migraine Headache Disorders: Neuromodulators have been used to treat forehead muscle groups that are involved with the migraine headache condition. Patients are advised that results of neuromodulator treatments for migraine headaches may be variable and improvement in this disorder may not occur following neuromodulator treatments. Unsatisfactory Result” There is the possibility of a poor or inadequate response from neuromodulator injections. Additional neuromodulator injections may be necessary. Surgical procedures or treatments may be needed to improve skin wrinkles including those caused by muscle activity. Long-Term Effects: Subsequent alterations in face and eyelid appearance may occur as the result of aging, weight loss, weight gain, sun exposure, pregnancy, menopause or other circumstances not related to neuromodulator injections. Neuromodulator injections do not arrest the aging process or produce permanent tightening of the eyelid region. Future surgery or other treatments may be necessary. Pregnancy and Nursing Mothers: Animal reproduction studies have not been performed to determine of neuromodulators could produce fetal harm. It is not known if neuromodulators can be excreted in human milk. It is not recommended that pregnant women or nursing mothers receive neuromodulator treatments. Drug Interactions: The effect of neuromodulators may be potentiated by aminoglycoside antibiotics or other drugs known to interfere with neuromuscular transmission.